Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
other:

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
During the test period, the temperature and humidity of the animal room were recorded by measure data in every 1 hr with an automatic temperature and humidity meter in every 5 min intervals.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test substance was orally administered once.
Doses:
10 mL/kg Body weight
No. of animals per sex per dose:
1st step(300 mg/kg bw): 3/female
2nd step(300 mg/kg bw): 3/female
3rd step(2,000 mg/kg bw): 3/female
Control animals:
no
Details on study design:
1. Room No.: Rodent 4
2. Cage type and size: Stainless wire cage (420 W×270 L×180 H mm)
3. Animals per cage: 3 animal/cage (during the study)
4. Temperature: 21.0 ~ 23.5 ºC
5. Relative humidity: 45.5 ~ 57.7%
6. Air exchange: 10 ~ 15 / hr
7. Light cycle: 12 hour light / 12 hour dark
8. Illumination: 150 ~ 300 lux
9. Water: Public tap water was filtered and irradiated by ultraviolet light and with ad libitum bottle using automatic feed water system. The absence of contamination was confirmed with periodical analysis results report of manufacture.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals died in the test substance administration group at 2000 mg/kg body weight (3 rd step) respectively. No dead animals were observed in the remaining 300 mg/kg body weight (1 st step and 2 nd step) test substance administration group.
Clinical signs:
Prone position was observed for all animals 30 minutes after administration in 2000 mg / kg administration group (3 rd step). At 1 hour after administration, Prone position, Soiled perineal region and Soft stool were observed in all animals, one died, the other two showed the same clinical signs and died at 4 hours.
No clinical signs were observed at 300 mg/kg body weight (1 st step and 2 nd step) throughout the study.
Body weight:
Survival animals showed normal gains in body weight.
Gross pathology:
In necropsy finding of died animals, Soiled perineal region were observed in all died animals. There were no necropsy findings caused by administration of test substance in all survived animals.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was classified into GHS (Globally Harmonized Classification System for Chemical Substances and Mixtures) Category 4 in this study.